制药工程复习题.doc

out city created, and care masses life, focus work, in-depth investigation, more out boutique masterpiece, makes we of research results more to into led of decision vision, more to in national some has effect of newspaper Shang published, for advance work, and publicity changde play due of role. Third, information submitted to be pragmatic. Quick and timely. The ancients said: for the time system; statement back for the time being, nothing. Therefore, the submission of information to do four, that is, find the problem faster, editorial writing, send and read faster approval and feedback to implement quickly. To be true and accurate. True mainly reflect the full picture of events, one is one, two, this is the life of the information. Accuracy is primarily qualitative and quantitative questions, quantitative objective of publicQualitative logic. To be reliable and useful. We submit information to have access to decision-making, to guide and promote the work and solve practical problems. Mixed cum. On the negative information and emergency information, rapid escalation in strict accordance with the procedures, firm, newspaper, newspapers, never late, fail to report, false claim and skimming. Investee 2. supervision and insist on, around and protecting their interests to touch the truth, seek practical results. Adhere to people-oriented, the most important thing is to realize, safeguard and develop the fundamental interests of the overwhelming majority of the people. We carry out inspection, so must go deep among the masses, go deep into the realities, always pay attention to the peoples livelihood, to grasp the public sentiment, and earnestly safeguard the benefit, addressing the masses are most concerned about and reflecting the strongest issues, efforts to solve the problem of decisions implemented and not implemented. One is to stick to principles. Right of inspection is one of the most important powers of the Office, should not only dare to use, but also with caution. So-called dared to use, is to hold a number of important issues, bold supervision over supervision, track inspection, problems are not solved do not pass, the blame does not hold did not miss, dissatisfaction of the masses did not miss, the real right of supervision authority, with the benefits. Call with caution, is supervising departments should strengthen the consciousness of authorized strictly according to procedure, preventing the supervision and excessive to prevent adding burden to grass-roots. To this end, the supervision Department of the Party Committee of supervision must be under city and County party Committee Secretary-General (Office). Second, we should focus on. Is the Governor, those related to the globalEvent, Governor the protracted difficult, strong Governor during emergency urgent. Not having special departments in charge of the General Governor, under the normal procedure can do good things not Governor, not authorized by County leaders, not the Governor. Third is to solve the problem. The purpose of supervision, to resolve the problem. To adhere to and further improve the选择题 题目选自2010版GMP实施条例下列哪部分不属于车间的辅助生产部分。（ C ） A、物料净化用室 B、洁净工作服洗涤干燥室 C、换鞋室 D、空调室10. 隧道式灭菌烘箱结构上起干燥灭菌作用的是（ B ）。A、预热段 B、高温段 C、冷却段 D、降温段11. 药品GMP认证可分为 （ D ）。 A、 标准认证和安全认证 B、 标准认证和企业认证 C、 企业认证和计量认证 D、 企业认证和品种认证 E、 产品认证和计量认证 12. 药品质量的主要负责人是（ A ）。 A、企业负责人； B、生产管理负责人； C、质量管理负责人； D、质量受权人；13. 质量管理负责人至少具有（ B ）年从事药品生产和质量管理的实践经验，其中至少（ ）年的药品质量管理经验，接受过于所生产产品相关的专业知识培训。 A、 3, 1； B、 5, 1； C、 5 , 2 D、 3, 2 14. 以下哪位主要负责：承担产品放行的职责，确保每批已放行产品的生产、检验均符合相关法规、药品注册要求和质量标准。（ D ） A、企业负责人； B、生产管理负责人； C、质量管理负责人； D、质量受权人；15. 批生产记录在填写过程中（ B ） A、允许更改，但要将原数据完全涂掉，填写更改清楚数据，并签名 B、允许更改，但不能将原数据完全涂掉，应使原数据仍可辨认，在更改处签名 C、允许更改，但经车间负责人批准，将填写记录撕掉，重新填写，责任人签字 D、允许更改，经车间负责人批准，注明“作废”，保留原错填记录，然后重新填写，并签名 E、根本不允许更改，按作废处理，重新填写，签名 16. 中间产品和待包装产品应当有明确的标识，可以不用表明的内容是（ E ） A、产品名称和企业内部的产品代码； B、产品批号; C、数量或重量 D、生产工序 E、保质期17. 仓储区内的原辅料应当有适当的标识，以下可以不用表明的内容是（ E ） A、 制定的物料名称和企业内部的物料代码； B、 企业接受时设定的批号 C、 物料质量状态（待验、合格、不合格、已取样） D、 有效期或复验期 E、 数量或重量18. 生产时，应避免与其它药品使用同一设备和空气净化系统的药品是（ E ） A、 生化制品、普通制品 B、 放射性药品、一般药品 C、 毒性药品、外用药 D、 激素类药品E、 激素类、抗肿瘤类化学药品19. 以下哪个操作属于包装（ A ）A、 待包装产品的分装 B、 中间产品的包装 C、 无菌生产工艺中产品的无菌灌装 D、 最终灭菌产品的灌装20. GMP规定，批生产记录应（ B ） A、 按生产日期归档 B、 按批号归档 C、 按检验报告日期顺序归档 D、 按药品入库日期归档 E、 按药品分类归档 9. 下列哪个区域应放置在上风区。（ C ） A、锅炉房 B、原料药 C、行政-生活区 D、动物房10. 下列哪个不是制剂机械。（ D ）A、混合机 B、制粒机 C、压片机 D、空调净化设备填空题1、 饱和蒸汽冷凝时，传热膜系数下降，可能的原因是-2、厂房设计与洁净技术三协调原则工艺流程协调、人流物流协调、洁净级别协调3、任何药品质量形成是设计和生产出来的，而不是检验出来的4、QA是指- QC是指 -5、HVAC系统是指6、风玫瑰图是指7、旋风分离器适用于分离8、多效浓缩罐中多效是指9、洁净室要求温度和湿度一般是-10、洁净室中最大的污染源是-11、 新风比是指 - 单向流洁净室新风风量占总风量-12、工艺用水是药品生产工艺中使用的水，其中包括饮用水、纯化水和注射用水。问答题1、 2010版GMP对空气洁净度的要求按照ABCD进行划分。请叙述ABCD洁净级别的具体要求，以及不同洁净级别之间的区别。从英制标准中把1立方英尺中直径0.5m 的微粒数作为洁净级别的级别，100级，指每立方英尺中的粒子数有100个。 1米 = 3.28英尺1米3 = 35.29英尺3 级别静态动态尘粒最大允许数/m30.5m5m0.5m5mA3500135001B350012000C200020000D20000不作规定不作规定微生物污染限度参考标准(a)级别空气样cfu/m3沉降碟(F90mm)cfu/4小时(b)接触碟(F55mm)cfu/碟5指手套cfu/手套A1111B10555C1005025D20010050A级指高风险操作区，如：灌装区、放置胶塞桶、敞口安瓿瓶、敞口西林瓶的区域及无菌装配或连接操作的区域。通常用层流操作台（罩）来维持该区的环境状态。层流系统在其工作区域必须均匀送风，风速为0.36-0.54m/s B级指无菌配制和灌装等高风险操作A级区所处的背景区域。C级和D级指生产无菌药品过程中重要程度较次的洁净操作区 A级是动态百级层流,B级是A级的背景级别,百级乱流级洁净区相当于原来的万级；级洁净区相当于原来的十万级。 2、 冻干制剂中，第一干燥阶段和第二干燥阶段对真空度的要求是什么？请解释原因。第一阶段真空度不能太高的原因是答题重点在一级干燥阶段，为防止载体受热不均，真空控制下限在250 mHg，当真空过低时，要充氮加热，充气控制在+30mHg，形成稳定气流及干燥速度二级干燥属真空干燥，其目的是去除吸附水，真空越低越好，不必担心真空过高，但在停机时，真空下降值应控制在3000瓶，可信限为95%时污染率为0.1%或小于0.1%的指标作为合格标准是可以被认可的。提取中冷凝水怎么回收？整个外脚手架工程涉及到搭设、维护及拆除三个阶段，根据各个阶段的不同工作内容，劳动力的需用情况不同。本工程主体施工进度要求较快，外脚手架工作量较大，需投入较多劳动力，外脚手架将根据现场分栋搭设。外脚手架维护阶段主要是配合外装单位进行施工，因此需用劳动力较少feelings survey, by looking up public sentiments to find problems. Problems will increase its special supervision, set up accounts, hold on to it. We should conscientiously implement the leading contracting matters, secured, had an answer to everything, then settles rate of 100%. Have an impact on some of the outstanding issues, supervision departments and information components together, play the supervisory role of the news media to promote problem solving. Investee 3. insist on a daily run, around the practice of truth catching efficiency, focus specification. To give full play to the party Office around connecting, coordinating internal and external features, contact, rally at all levels, to motivate every aspect, adhere to the truth, strengthening standardized management to achieve coherent, efficient and effective functioning of the daily work of the Party Committee. Is processing messages should strive to streamline, standardize and quality. Streamlining is to control the number of messages, compress messages, reducing procedures, improve message handling efficiency. Specifications, is to strictly enforce the ban issued by the Communist party authorities in document handling regulations and provincial and municipal regulations, conscientiously strengthen and improve communications management to ensure that party documents orderly. High quality, is to improve the quality of message processing, it is necessary to accurately implementing the intention of the Party Committee, clearance, good communications, policy program closed, ensuring that there is no error. Second meeting scheduled to ensure thorough, safe and efficient. Any arrangements for the meetings and events, carefully arranged, item-by-item interface implemented, sure. To vigorously streamline meetings, activities, number of pressure reduction, scale to ensure that leadership emerged from the General Conference and entertainment services, focus on big things, matters. Third, reception services should lay stress on humane, personal, cultural and human. Reception and work directly with people, reception services directly affecting the Office of party Committee The image of the region. At the same time strengthening the construction of library, impro